Systems used in academic trials

Hello

If a commerically available system like SAS, STATA, R or others is used for analysis, or a GCP compliant data entry system like Inform, OpenClinica or Infermed is utilised in a study, is there a requirement for sponsors to undertake addtional validation of the systems beyond what is done by the manufacturers? We are being asked to prepare detailed validation documentation on a study by study basis for all systems that are used in that particular study, regardless of their origin, and it seems rather excessive and time consuming. We are told it is required by the MHRA.

It also seems rather pointless if the people requesting and reviewing the detailed information have a minimal grasp of analysis or computer systems and I suspect if this becomes commonplace, it will do more harm than good to academic research.

I think what is being referred to here is validation of fitness for purpose for your application of the software. It would not be expected that you would do a full validation of the software as it's out with your scope within a CTU.

What is expected is that you test the system you want to use by formally documenting a plan, its execution and its results, set your own pass criteria and report the progress on meeting your targets. It is essential to stress test your planned use such that you can provide operational limits.

Commercial off-the-shelf packages would not require revalidation, but it may be appropriate to undertake installation, operational and performance qualifications. The key requirement is that any trial specific configuration/build/programming etc within the system is evaluated as fit-for-purpose (validated) and that this assessment is appropriately documented. For further information see the MHRA GCP Guide 14.5.